TEMAZEPAM capsule

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

temazepam (UNII: CHB1QD2QSS) (temazepam - UNII:CHB1QD2QSS)

Tillgänglig från:

TYA Pharmaceuticals

Administreringssätt:

ORAL

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

Temazepam Capsules, USP are indicated for the short-term treatment of insomnia (generally 7 to 10 days). For patients with short-term insomnia, instructions in the prescription should indicate that Temazepam Capsules, USP should be used for short periods of time (7 to 10 days). The clinical trials performed in support of efficacy were 2 weeks in duration with the final formal assessment of sleep latency performed at the end of treatment. Benzodiazepines may cause fetal harm when administered to a pregnant woman. An increased risk of congenital malformations associated with the use of diazepam and chlordiazepoxide during the first trimester of pregnancy has been suggested in several studies. Transplacental distribution has resulted in neonatal CNS depression following the ingestion of therapeutic doses of a benzodiazepine hypnotic during the last weeks of pregnancy. Reproduction studies in animals with temazepam were performed in rats and rabbits. In a perinatal-postnatal study in rats, oral doses of 60 mg/kg/

Produktsammanfattning:

NDC:64725-1460-1 in a CONTAINER of 30 CAPSULES

Bemyndigande status:

Abbreviated New Drug Application

Bipacksedel

TYA Pharmaceuticals
----------
MEDICATION GUIDE
Read the Medication Guide that comes with TEMAZEPAM before you start
taking it and each time you
get a refill. There may be new information. This Medication Guide does
not take the place of talking to
your doctor about your medical condition or treatment. You have a
higher chance for doing these
activities if you drink alcohol or take other medicines that make you
sleepy with TEMAZEPAM.
Reported activities include: • driving a car (“sleep-driving”)
• making and eating food • talking on the
phone • having sex • sleep-walking • Do not take more TEMAZEPAM
than prescribed. • Take
TEMAZEPAM right before you get in bed, not sooner. • drink alcohol
• take other medicines that can
make you sleepy. Talk to your doctor about all of your medicines. Your
doctor will tell you if you can
take TEMAZEPAM with your other medicines • cannot get a full
night’s sleep TEMAZEPAM is a
sedative-hypnotic (sleep) medicine. TEMAZEPAM is used in adults for
the short-term (usually 7 to 10
days) treatment of a sleep problem called insomnia. Symptoms of
insomnia include: • trouble falling
asleep • waking up often during the night TEMAZEPAM is not for
children. TEMAZEPAM Capsules,
USP C-IV (temazepam)
What is the most important information I should know about TEMAZEPAM?
After taking
TEMAZEPAM, you may get up out of bed while not being fully awake and
do an activity that you do not
know you are doing. The next morning, you may not remember that you
did anything during the night.
Call your doctor right away if you find out that you have done any of
the above activities after taking
TEMAZEPAM. Important: 1. Take TEMAZEPAM exactly as prescribed
2. Do not take TEMAZEPAM if you:
What is TEMAZEPAM?
TEMAZEPAM is a federally controlled substance (C-IV) because it can be
abused or lead to
dependence. Keep TEMAZEPAM in a safe place to prevent misuse and
abuse. Selling or giving
away TEMAZEPAM may harm others, and is against the law. Tell your
doctor if you have ever
abused or be

Produktens egenskaper

TEMAZEPAM - TEMAZEPAM CAPSULE
TYA PHARMACEUTICALS
----------
RX ONLY
DESCRIPTION
Temazepam is a benzodiazepine hypnotic agent. The chemical name is
7-chloro-1,3-dihydro-3-hydroxy-
1-methyl-5-phenyl-2 -1,4-benzodiazepin-2-one, and the structural
formula is: _H_
C H CIN O MW = 300.74 Temazepam is
a white, crystalline substance, very slightly soluble in water and
sparingly soluble in alcohol USP.
Temazepam Capsules, USP, 7.5 mg, 15 mg, 22.5 mg and 30 mg, are for
oral administration. Active
Ingredient: temazepam USP Corn starch, lactose anhydrous, magnesium
stearate, sodium lauryl sulfate,
FD&C Red #40 and titanium dioxide. Corn starch, lactose anhydrous,
magnesium stearate, sodium lauryl
sulfate, FD&C Blue #1, FD&C yellow # 6, gelatin and titanium dioxide.
sodium lauryl sulfate.
Imprinting ink may contain ammonium hydroxide, ethanol, isopropyl
alcohol, butanol, shellac, potassium
hydroxide, propylene glycol, and black iron oxide. Corn starch,
lactose anhydrous, magnesium stearate,
sodium lauryl sulfate, FD&C Blue #1, FD&C Red #40, gelatin and
titanium dioxide. sodium lauryl
sulfate. Imprinting ink may contain ammonium hydroxide, ethanol,
isopropyl alcohol, butanol, shellac,
potassium hydroxide, propylene glycol, and black iron oxide. Corn
starch, lactose anhydrous,
magnesium stearate, sodium lauryl sulfate, gelatin and titanium
dioxide. sodium lauryl sulfate. Imprinting
ink may contain ammonium hydroxide, ethanol, isopropyl alcohol,
butanol, shellac, potassium hydroxide,
propylene glycol, and black iron oxide.
_7.5 MG, 15 MG, 22.5 MG AND 30 MG CAPSULES_
_7.5 MG CAPSULES_
_Inactive Ingredients:_
_sodium lauryl sulfate. Imprinting ink may contain ammonium hydroxide,
ethanol, isopropyl alcohol, butanol,_
_shellac, potassium hydroxide, propylene glycol, and black iron
oxide.May also include:_
161322
_15 MG CAPSULES_
_Inactive Ingredients:_
_May also include:_
_22.5 MG CAPSULES_
_Inactive Ingredients:_
_May also include:_
_30 MG CAPSULES_
_Inactive Ingredients:_
_May also include:_
CLINICAL PHARMACOLOGY
In a single and m